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K' I'I fk85fective i DOG <br /> Na. fIYSI2Ii-O -x5-06 <br /> Certification of EO Sterilization PUtdcGf fj version <br /> 1n/AnY1 sITYJ11/A'noN 'I;xUl <br /> i Ul EfNa.date: 01M 05 <br /> A te, Report no.:2021072125 <br /> SP Customer ( YIWU CITY SOLONG IMP & EXP CO., LTD ) <br /> Y'Ah :98 Product name H* Specification i iBatch ( Quantity <br /> Tattoo Needle Cartridge RL RLT RM RS 07/2021 28 ' <br /> Xffi ixASterilization mode K'$LLjrLEDgas TcVEM9 sterilizerno. HYST/ST-02 <br /> XM F1 M Sterilization date 2021-07-20 X]Ii Sterilization batch 2021072002A <br /> XfVt Sterilization parameters ' Requirements �tVTaActual <br /> Unit y({� Validated Min. Max. Min. I Max. <br /> i"nu1AXNN E39 10mjE Loading tem. prior to preconditioning °C $10.0 10.0 / 36.4 <br /> RA3NZA Preconditioning temperature °C 48.0 44.0 52.0 46.6 51.9 <br /> MALE&& Preconditioning RH %RH 55.0 30.0 80.0 44.8 55.5 <br /> TBEZRIN Preconditioning time Minute 360 340 380 360 <br /> 09 Hit f7 Transfer time Minute X60 / 60 / <br /> ]Wl Initial evacuation depth kPa -37.0 -39.0 -35.0 -37.1 <br /> M 5!M* Evacuation rate kPa/min 54.0 / 4.0 2.3 <br /> 19-JERff7 Pressure holding time Minute 20 10 30 20 <br /> Leak test pressure rise & P kPa <_1.0 / 1.0 0.8 <br /> aW%aABtj7 ( 9AM ) Moisture Injection time (if used) Minute 30 10 <br /> EO %A31* EO injection rate kPa/min 0.5 0.3 0.7 0.6 <br /> XMPJSfit EO Injection weight kg 20.0 1915 2045 19.5 <br /> EO Pressure rising after EO injection OP kPa 231.0 31.0 / <br /> AP:33.1 <br /> EO MgE EO concentration commence of exposure (theorical) mg/I 600 400 800 639 <br /> 7E-AVEjEExposure temperature °C 52.0 49.0 55.0 52.6 54.7 <br /> XMMIY Exposure RH %RH 55.0 30.0 80.0 52.6 66.4 <br /> X111101 Exposure time Minute 720 700 740 720 <br /> MJF L1 Post-evacuation depth kPa -25.0 -27.0 -23.0 -25.1 -25.0 <br /> Aa4L.EEj0 Inflation pressure kPa -5.0 -7.0 -340 -5.1 -5.0 <br /> A' MY1 Number of repetition Times 26.0 6 / 6 <br /> '°t8tj7 Duration of flushing Minute 105 90 120 108 <br /> BI 5EX-1490** 81 test of sterility 'X. o 't Conformity; ❑ *o� non-conformity, <br /> j¢ Conclusion , <br /> The sterilization cycles were performed <br /> asperthe validated parameters with no deviations. •� <br /> 19*11 Prepator: 4 ��W✓ H 1W Date: / <br /> 90W Approval(QA): ���-�p q� ' " . ( FIM Da l <br /> �tI�FLTc�#x p tR�" 14H � <br /> Zhejiang Huanyi Steri tign.�c� ogy Co., Ltd. ( stamp ) <br /> Nl Al' lilAk QUALITY RECORD I I <br />